HEALTH RESEARCH ETHICS COMMITTEE 1 & 2

ANNUAL PROGRESS/FINAL REPORT FOR HEALTH/HUMAN RESEARCH

(INFORMATION SHOULD BE TYPED)

SECTION A: REPORT TYPE (pleasecheck[x] appropriate box)
☐Final report (to be submitted after study/site closure)
☐Annual progress report (request for extension/annual renewal of ethics approval)
Reporting Period: From dd/mm/yyyy to dd/mm/yyyy
SECTION B: DETAILS OF PRINCIPAL INVESTIGATOR
Title, First name, Surname:
University DIVISION:
University DEPARTMENT:
Present position:
Telephone number: / E-mail:
SECTION C: PROJECT DETAILS
Title of study: / HREC Ref No:
Approval date: / Start date: / Expected date of completion:
SECTION D: FUNDING – HOW IS THE PROJECT FUNDED? (please check [x] appropriate box)
  1. Industry
/
  1. NIH/US government funded research

  1. Other international grant funded research (e.g. Wellcome Trust)
/
  1. National grant funded research (e.g. NRF, MRC, CSIR, etc)

  1. Harry Crossley funded research
/
  1. Research funded solely from SU departmental budget

  1. Self funded research
/
  1. Non-sponsored student research for degree purposes at Stellenbosch University

SECTION E: PARTICIPANTS (SU SITES ONLY)
Expected number of participants (total)
Number of participants enrolled with verbal/written informed consent
Number of participants enrolled with an approved waiver of consent (e.g. records examined)
If this study is a laboratory based study: Number of blood/other samples collected/examined
Number of participants withdrawn before completion. (Provide details in Section F)
Number of participants already completed
SECTION F: SUMMARY OF PROGRESS TO DATE (Refer to the number of participants recruited, participant retention,
withdrawals, unanticipatedproblems, adverse events, positive outcomes, etc.)
Participant recruitment
(Detail the number of participants recruited)
Participant retention
(Summary of any withdrawal of participants from the research since the last REC review)
Unanticipated problems
(Summary of unanticipated problems, in some cases such a summary could be a simple brief statement that there have been no unanticipated problems)
Adverse events (this does not include SAEs)
(Summary of available information regarding adverse events, in some cases such a summary could be a simple brief statement that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document and any investigator brochure)
Positive outcomes
Publications/Dissemination of results
(List of publications from this research and/or summary of other media for dissemination of results)
SECTION G: SERIOUS ADVERSE EVENTS
Local Site / South Africa / Global / Local site / South Africa / Global
Number of SAE’s for reporting period / Total number of SAE’s since start of trial
Summary of LOCAL SITE SAE’s for reporting period
Ref. No./
Participant No. / Date / Event / Causality
(Related/ unrelated/
unknown) / Outcome
(Resolved/ unresolved/ death) / Previously reported to HREC (Yes/No)
SECTION H: PROTOCOL NON-COMPLIANCE (please attach details)
Local Site / South Africa / Global / Local Site / South Africa / Global
Number of protocol deviations for reporting period / Total protocol deviations
Summary of LOCAL SITEDEVIATIONS for reporting period
Ref. No. (If applicable) / Date / Incident / Explanation
SECTION I: ATTACHMENTS
Kindly indicate if you have attached any of the following documentation. Include documents only if relevant to your progress report application.
Current informed consent documents
Relevant multi-centre trial reports e.g. DSMB reports
Published articles or abstracts
Literature (a summary of any recent literature that may be relevant to the research)
SECTION J: SIGNATURE
…………………………………………………….. ……………………………………… ………………………………………..
Signature of Principal Investigator Print name Date

INSTRUCTIONS: How to submit a progress report

CLINCIAL TRIALS, human/HEALTH and student research:

  1. 1 hard copy of full application

•Submit to Elvira Rohland, room 5007, 5th floor, teaching block, Faculty of Medicine and Health Sciences

AND

  1. 1 electronic copy of full application

•Submit inoneemail

•Submit any documents created in Microsoft word as either word documents or .pdf files

•Submit a scanned .pdf file of each signed document

HREC Progress Report/Final report Health/Human Research Form V4.5June 2015Page 1 of 5

Stellenbosch University, Faculty of Medicine and Health Sciences

GUIDELINES FOR COMPLETING PROGRESS REPORTS

(NB. Please delete this Page before you print out and submit your progress report.)

  1. Ethics approval is valid for one year only. A progress report is an application for renewal of ethics approval and must be submitted annually, well before the ethics approval expiry date, so that the progress report can be reviewed and the project re-approved prior to the expiry date. No research may continue without this process and re-approval. NB! Six monthly progress reports may occasionally be requested if the HREC deems the project to be of particularly high risk.
  1. All clinical trials falling under the jurisdiction of the MCC must submit a progress report to the MCC six monthly and should provide the REC with a copy of this report. However a site specific progress report must be submitted annually, for ethics reapproval, using this format.
  1. The progress report should contain sufficient information to allow the reviewer to conduct a substantive and meaningful review of the progress of the project, including any challenges or problems encountered.
  1. For multi-centre studies the information in the progress report must pertain specifically to SU sites.
  1. An updated complete protocol, incorporating all approved amendments should be submitted approximately every three years unless there have been no, or minimal changes to the project. If so, state this in the progress report.
  1. Copies of published abstracts and/or papers, may be submitted as attachments, but may NOTreplace text required in Section F.
  1. All investigators whose projects are funded by US government federal funds (NIH, CDC etc) must comply fully with OHRP requirements for continuing review. These can be found at

HREC Progress Report/Final report Clinical Trials Form V4.3Oct 2014Page 1 of 5

Stellenbosch University, Faculty of Medicine and Health Sciences